MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-26 for OLYMPUS 7272740 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[107081210]
Olympus keymed has requested for the product to be returned for further investigation. Awaiting product return. No report of injury to patient or user. Reported in abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[107081211]
The tc - tr2 trolley was being transported to the equipment room. While being maneuvered one of the castors became loose and came off. There are no reports of the trolley falling over or reports of injury to patient or user.
Patient Sequence No: 1, Text Type: D, B5
[120003857]
Investigation completed by olympus keymed investigator. Investigator concluded that tc-tr2 trolley had exceeded it's life expectancy of 5 years. The tc-tr2 trolley was manufactured in 2001 and has been confirmed as 17 years old. Product support ceased on 30 october 2012 and the tc-tr2 trolley is no longer serviceable. There was no reported patient harm or injury related to this complaint and has been reported in the abundance of caution. This will be the final follow-up report to be submitted, however if any new information is received we will issue an additional follow-up report for this adverse event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611174-2018-00007 |
| MDR Report Key | 7463614 |
| Date Received | 2018-04-26 |
| Date of Report | 2018-06-18 |
| Date of Event | 2018-04-03 |
| Date Mfgr Received | 2018-05-31 |
| Device Manufacturer Date | 2001-05-10 |
| Date Added to Maude | 2018-04-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS AIMILIA GKARAFLI |
| Manufacturer Street | KEYMED HOUSE, STOCK ROAD |
| Manufacturer City | SOUTHEND ON SEA, ESSEX SS2 5QH |
| Manufacturer Country | UK |
| Manufacturer Postal | SS2 5QH |
| Manufacturer Phone | 0441702616 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OLYMPUS |
| Generic Name | MONITOR TROLLEY TC-TR2 |
| Product Code | FEM |
| Date Received | 2018-04-26 |
| Model Number | 7272740 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. |
| Manufacturer Address | KEYMED HOUSE, STOCK ROAD SOUTHEND-ON-SEA, ESSEX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-26 |